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# Enhertu sBLA Priority Review for Solid Tumors
- URL: https://www.fdaweb.com/enhertu-sbla-priority-review-for-solid-tumors/
- Published: 2024-01-30T12:00:00.000Z
- Updated: 2026-09-14T14:21:33.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156252

FDA has accepted for priority review an AstraZeneca and Daiichi Sankyo supplemental BLA for Enhertu (trastuzumab deruxtecan) for treating adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior treatment or who have no satisfactory alternative treatment options.

The submission is based on data from the ongoing DESTINY-PanTumor02 Phase 2 trial where Enhertu demonstrated “clinically meaningful and durable responses leading to a clinically meaningful survival benefit in previously treated patients across HER2-expressing metastatic solid tumors, including biliary tract, bladder, cervical, endometrial, ovarian cancers, and other tumors,” according to the companies. The sBLA is being reviewed under the agency’s Real-Time Oncology Review program and Project Orbis.

Enhertu is described as a specifically engineered HER2-directed antibody drug conjugate being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. It is currently approved for treating certain patients with unresectable or metastatic HER2-positive and HER2-low breast cancer.